Allergan Inc. is facing a federal subpoena concerning its controversial weight-loss surgical device, Lap-Band.
Lap-Band is implanted around the stomach to curb an obese person’s appetite. It is designed to promote rapid weight loss but has been associated with a growing number of unexpected complications and side effects blamed not only on the device but also on the surgeon’s implanting it.
According to a Bloomberg report, the subpoena against Allergan has been sourced to the Dept. of Health and Human Services and concerns a recent Congressional call for a hearing to discuss the safety of Lap-Band after a report in Archives of Surgery associated the devices with an extremely high failure rate and a link to “long term complications.” That study found that about half of all Lap-Band recipients were contemplating a removal of the devices after just six years and nearly 40 percent of patients were bound to suffer long term pain and injuries rooted to the devices.
Earlier this year, despite growing evidence that Lap-Band could be defective and dangerous by design and that a vast number of surgeons haven’t been well-versed in proper procedures for implanting them, the Food and Drug Administration approved the surgery for people with less severe cases of obesity, potentially putting thousands more people at risk of similar injuries.
In Southern California, the Lap-Band and so-called boutique surgical centers created almost exclusively to implant these devices has been tied a growing controversy. The 1-800-GET-THIN billboard promotion in that area of the state has been stopped after it was learned the surgeons at associated surgery centers were not implanting them properly and had caused at least five deaths since 2009. The surgery centers implanting the devices in California were accused of not providing adequate warning of the risks associated with Lap-Band.
In addition to that risk, the design of Lap-Band has also been linked to serious complications, including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea and vomiting.
These complications likely will lead to a life of pain and discomfort followed by possible repeated revision surgeries to adjust Lap-Band, or a surgery to remove the device far sooner than expected.
Lap-Band was first approved in 2001 for the treatment of morbid or serious obesity, for people at least 100 pounds overweight or for those with a Body Mass Index of 40 or greater. Prospective patients with lower BMI were also candidates for Lap-Band if they were suffering from a related condition such as heart disease which meant their obesity only increased their risks of suffering other related complications. An amended approval of Lap-Band earlier this year lower the minimum BMI for surgery candidates and put less restrictions on the severity and amount of related conditions a patient could have before receiving the device.